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Clinical Trials in China / NCT03206814
Recruiting Not applicable

Improving Hypertension Control in CHina and ARGEntina With a Mobile APP-based Telecare System

NCT03206814 · tracked via the Priya Life Science China tracker
Sponsor
Istituto Auxologico Italiano
Phase
Not applicable
Started
2021-05-11
Last updated
2025-02-27

Condition(s) studied

Hypertension,EssentialHypertension, Uncontrolled

Investigational drug(s) / intervention(s)

Usual carePOST-strategy

Usual care: Antihypertensive therapy is adjusted every 3 months on the basis of office blood pressure values.

POST-strategy: Antihypertensive therapy is adjusted every 15 days on the basis of home blood pressure values.

Study summary

The CHARGE-APP project will investigate whether an innovative management strategy of hypertension based on the combination of usual care visits and ESH CARE App compared to standard care, is associated with differences in outcome, including control rate of office, home and ambulatory BP, cardiovascular and renal intermediate end points at one year, and changes in a number of blood pressure-related variables throughout the study.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Male and female subjects; * Age 18-80 years; * Either the patient or another person close to him/her should possess a smartphone compatible with the ESH CARE app and be capable of using it; * Uncontrolled (untreated or treated) hypertension, defined as office BP ≥140/90 mmHg, and Ambulatory 24h ABP ≥130/80 mmHg Exclusion Criteria: * eGFR \<45 mL/min/1.73 m2 (CKD-EPI creatinine equation 2009); * Severe uncontrolled hypertension (i.e. BP ≥200/120 mmHg despite treatment); * Known secondary hypertension; * Orthostatic hypotension (SBP fall \> 20 mmHg on standing); * Unstable clinical conditions or severe disease with short life expectation; * Known atrial fibrillation; * Hepatic disease as determined by either AST or ALT values \> 2 times the upper limit of normal; * History of gastrointestinal surgery or disorders which could interfere with drug absorption * History of malignancy including leukaemia and lymphoma (but not basal cell skin cancer) within the last 5 years; * History of clinically significant autoimmune disorders such as systemic lupus erythematosus; * History of drug or alcohol abuse within the last 5 years; * History of non-compliance to medical regimens and/or patients who are considered potentially unreliable; * Dementia (clinical diagnosis); * Inability or unwillingness to give free informed consent; * Inability to use even simple communication technologies; * Pregnancy or planned pregnancy during study period

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
Private Hospital " Dr Raúl Matera" Bahía Blanca Argentina Recruiting
Argerich Hospital Buenos Aires Argentina Recruiting
General San Martin Hospital of La Plata La Plata Argentina Recruiting
Spanish Hospital of Mendoza Mendoza Argentina Recruiting
British Sanatorium of Rosario Rosario Argentina Recruiting
Shanghai Institute of Hypertension Shanghai Huangpu Recruiting
Jiangsu Province Official Hospital Jiangse China Active Not Recruiting
Ruijin Hospital North Shanghai China Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03206814 on ClinicalTrials.gov ↗ ← All trials in China